EUCTR2006-001084-27-IT
Active, not recruiting
Not Applicable
Phase I/II study of prevention of Colorectal Cancer CRC with Allopurinol in High-Risk Subjects - APAC
AZIENDA OSPEDALIERA OSPEDALI GALLIERA0 sites75 target enrollmentMarch 1, 2007
ConditionsCHEMOPREVENTION OF COLORECTAL CANCERMedDRA version: 9.1Level: LLTClassification code 10048832Term: Colon adenoma
DrugsZYLORIC*30CPR 300MG
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- CHEMOPREVENTION OF COLORECTAL CANCER
- Sponsor
- AZIENDA OSPEDALIERA OSPEDALI GALLIERA
- Enrollment
- 75
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age 8805; 18 years, 75 years; 2\.Provision of written informed consent; 3\.Subjects with one ore more colorectal adenomatous polyps diam. 8805; 1 cm ; 4\.Adequate renal and hepatic function; 5\.Performance status 8804; 1;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Presence of iperplastic polyps and/or flat adenomas; Subjects with pre\-existing CCR; Presence of carcinoma tissue in adenoma; Previous allopurinol assumption within 6 months ; Pregnancy or breast feeding women of child\-bearing potential must have a negative pregnancy test within 7 days before the start of study treatment ; Known severe hypersensitivity to allopurinol or any of the excipients of this product; Geographic inaccessibility or proven difficulty to assure adequate compliance; Renal failure grade 1 creatinine 1\.5 x ULN ; Acute Gout; Subjects in anticoagulant therapy with dicumarol.
Outcomes
Primary Outcomes
Not specified
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